Impact of five prophylactic filgrastim schedules on hematologic toxicity in early breast cancer patients treated with epirubicin and cyclophosphamide
Impact of five prophylactic filgrastim schedules on hematologic toxicity in early breast cancer patients treated with epirubicin and cyclophosphamide
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DOI：
10.1200/jco.2005.03.099
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发表时间：
2005-10-01
影响因子：
45.3
通讯作者：
Calabresi, F
中科院分区：
文献类型：
--
作者：
Papaldo, P;Lopez, M;Calabresi, F
目的评价重组人粒细胞集落刺激因子不同强度方案的疗效（G-CSF;非格司亭）支持预防用相对高剂量的表阿霉素加环磷酰胺（EC）治疗的早期乳腺癌患者的发热性中性粒细胞减少症患者和方法从1991年10月至1994年4月，506名I期和II期乳腺癌患者随机接受，在析因2 × 2设计中，每21天第1天静脉注射依匹罗林120 mg/m2和环磷酰胺600 mg/m2，共4个周期+/-氯尼达明+/- G-CSF。每100名随机分配的患者测试以下五个连续的G-CSF方案：（1）皮下注射480 μ g/d，第8至14天;（2）480 μ g/d，第8、10、12和14天;（3）300 μ g/d，第8至14天;（4）300 μ g/d，第8、10、12和14天;（5）300 μ g/d，第8、12天。结果所有G-CSF方案均覆盖了中性粒细胞最低点时间。时间表5相当于每日时间表（附表1和3）和隔日附表（附表2和4）关于3级和4级中性粒细胞减少症的发生率（分别为P = 0.79和P = 0.89），发热发作率（分别为P = 0.84和P = 0.77），（分别为P = 0.74和P = 0.56），抗生素的需要（分别为P = 0.77和P = 0.88），以及延迟周期的百分比（分别为P = 0.43和P = 0.42）。G-CSF没有显着的影响，交付的剂量强度相比，非G-CSF arms.Conclusion在辅助设置，预防性G-CSF管理EC期间的频率可以减少到只有两个管理（第8和12天），而不改变结果。这项非随机试验设计为评估早期乳腺癌女性的替代性、强度较低的G-CSF方案提供了支持。
Purpose To evaluate the comparative efficacy of varying intensity schedules of recombinant human granulocyte colony-stimulating factor (G-CSF; filgrastim) support in preventing febrile neutropenia in early breast cancer patients treated with relatively high-dose epirubicin plus cyclophosphamide (EC).Patients and Methods From October 1991 to April 1994, 506 stage I and II breast cancer patients were randomly assigned to receive, in a factorial 2 x 2 design, epirubicin 120 mg/m(2) and cyclophosphamide 600 mg/m(2) intravenously on day 1 every 21 days for 4 cycles +/- lonidamine +/- G-CSF. The following five consecutive G-CSF schedules were tested every 100 randomly assigned patients: (1) 480 mu g/d subcutaneously days 8 to 14; (2) 480 mu g/d days 8, 10, 12, and 14; (3) 300 mu g/d days 8 to 14; (4) 300 mu g/d days 8, 10, 12, and 14; and (5) 300 mu g/d days 8 and 12.Results All of the G-CSF schedules covered the neutrophil nadir time. Schedule 5 was equivalent to the daily schedules (schedules 1 and 3) and to the alternate day schedules (schedules 2 and 4) with respect to incidence of grade 3 and 4 neutropenia (P =.79 and P =.89, respectively), rate of fever episodes (P =.84 and P =.77, respectively), incidence of neutropenic fever (P =.74 and P =.56, respectively), need of antibiotics (P =.77 and P =.88, respectively), and percentage of delayed cycles (P =.43 and P =.42, respectively). G-CSF had no significant impact on the delivered dose-intensity compared with the non-G-CSF arms.Conclusion In the adjuvant setting, the frequency of prophylactic G-CSF administration during EC could be curtailed to only two administrations (days 8 and 12) without altering outcome. This nonrandomized trial design provides support for evaluating alternative, less intense G-CSF schedules for women with early breast cancer.